BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR W/ INTEGRATED RESERVOIR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·November 15, 2018

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114691239·Titanium Base Abutment Round, Conical L6mm H1mm...

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

    NAIL, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code JDS·February 13, 2017

    BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PRO-FEMUR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 28, 2011

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·October 7, 2010

    NAIL, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDS·July 5, 2016

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017